Omron MIT Elite (HEM-7300-WE)

Description:

The Omron MIT Elite (HEM-7300-WE) is an automatic blood pressure monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements. Blood pressure measurements are taken from the upper arm. It is intended for self-measurement and home use. This device has been discontinued by the manufacturer but may be available through certain outlets.

Assessment:

While the technology used in the Omron MIT Elite (HEM-7300-WE), to measure blood pressure, has been declared as being equivalent to that used in a clinically validated device, no evidence has been published to show that the devices have been compared according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BP	Medaval	None	Although equivalence to another device is claimed, this has not been tested to MDR requirements.
BP	BIHS (UK and IRL)	Previous recommendation, now archived	Manufacturer declaration of equivalence
BP	ESH (Europe)	Self-measurement	Published evidence

Device Family:

Omron Elite 7300W (HEM-7300-EZ)B, Omron MIT Elite Plus (HEM-7301-ITKE7)B, Omron MIT Elite (HEM-7300-WE)B
Legend: B BIHS Derivative

Validation Publications for Equivalent Devices:

Note: This is a provisional list, as equivalence according to EU Regulation 2017/745 (e.g. MEDDEV 2.7/1 rev 4) is not proven. Accordingly, these publications are not used in the assessment of star-ratings.

Omron Elite 7300W (HEM-7300-EZ)

Grim CE, Grim CM. The Omron Elite 7300W home blood pressure monitor passes the European Society of Hypertension International Validation Protocol for women and men. Blood Press Monit. 2009 Apr;14(2):87-90. doi: 10.1097/MBP.0b013e328329d294. PMID: 19305188.

ESH-IP:2002 - Pass General population

Omron MIT Elite Plus (HEM-7301-ITKE7)

Tholl U, Lüders S, Bramlage P, Dechend R, Eckert S, Mengden T, Nürnberger J, Sanner B, Anlauf M. The German Hypertension League (Deutsche Hochdruckliga) Quality Seal Protocol for blood pressure-measuring devices: 15-year experience and results from 105 devices for home blood pressure control. Blood Press Monit. 2016 Aug;22(4):197-205. doi: 10.1097/MBP.0000000000000186. PMID: 26998590.

DHL:2007 - Pass General population (Note: 2009)